The Use PUL-042 to Reduce the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2

NCT ID: NCT04313023

Last Updated: 2023-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 217 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-09
• Study Completion Date: 2021-07-31

Brief Summary

Subjects who have documented exposure to SARS-CoV-2 (COVID-19) will receive 4 doses of PUL-042 Inhalation Solution or 4 doses of a placebo solution by inhalation over 10 days. Subjects will be followed for the incidence and severity of COVID-19 over 28 days. Subjects will be tested for infection with SARS-CoV-2 at the beginning, middle and end of the study.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

PUL-042 Inhalation Solution

PUL-042 Inhalation Solution given by nebulization on Study Days 1, 3, 6, and 10

Group Type: EXPERIMENTAL

PUL-042 Inhalation Solution

Intervention Type: DRUG

20.3 µg Pam2 : 29.8 µg ODN/mL (50 µg PUL-042) PUL-042 Inhalation Solution

Sterile saline for inhalation

Sterile saline for inhalation given by nebulization on Study Days 1, 3, 6, and 10

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Sterile saline for inhalation

Interventions

PUL-042 Inhalation Solution

20.3 µg Pam2 : 29.8 µg ODN/mL (50 µg PUL-042) PUL-042 Inhalation Solution

Intervention Type: DRUG

Placebo

Sterile saline for inhalation

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Subjects must have recent exposure to SARS-CoV-2 (such as repeated or extensive exposure to an infected individual(s) or cohabiting with a SARS-CoV-2 positive individual).

2. Subjects must be 50 years or older if the exposure is due to cohabitation.

3. Subjects must be free of clinical signs or symptoms of a potential COVID-19 diagnosis (Ordinal Scale of Clinical Improvement score of 0) with a SARS-CoV-2 infection symptom score (fever, cough, shortness of breath, and fatigue) of 0 in each category.

4. Spirometry (forced expiratory volume in one second FEV1 and forced vital capacity [FVC]) ≥70% of predicted value.

5. If female, the subject must be surgically sterile or ≥ 1 year postmenopausal. If of child-bearing potential (including being < 1years postmenopausal) and, if participating in sexual activity that may lead to pregnancy, the subject agrees to use an effective dual method of birth control (acceptable methods include intrauterine device, spermicide, barrier, male partner surgical sterilization, and hormonal contraception) during the study and through 30 days after completion of the study.

6. If female, must not be pregnant, plan to become pregnant, or nurse a child during the study and through 30 days after completion of the study. A pregnancy test must be negative at the Screening Visit, prior to dosing on Day 1.

7. If male, must be surgically sterile or, if not surgically sterile and if participating in sexual activities that may lead to pregnancy, be willing to practice two effective methods of birth control (acceptable methods include barrier, spermicide, or female partner surgical sterilization) during the study and through 30 days after completion of the study.

8. Ability to understand and give informed consent.

Exclusion Criteria

1. Previous infection with SARS-CoV-2.

2. Receipt of any vaccine for the prevention of COVID-19 (single or multiple doses).

3. A SARS-CoV-2 infection symptom score greater than 0 in any of the 4 catergories (fever, cough, shortness of breath or fatigue) at the time of screening (Ordinal Scale for Clinical Improvement score of 0).

4. Known history of chronic pulmonary disease (e.g., asthma [including atopic asthma, exercise-induced asthma, or asthma triggered by respiratory infection], chronic pulmonary disease, pulmonary fibrosis, COPD), pulmonary hypertension, or heart failure.

5. Any condition which, in the opinion of the Principal Investigator, would prevent full participation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Pulmotect, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Colin Broom, MD

Role: STUDY_DIRECTOR

Pulmotect, Inc.

Locations

University of California Irvine

Orange, California, United States

Premier Urgent Care of California

San Bernardino, California, United States

Clinical Research of South Florida Alliance for Multispecialty Research

Coral Gables, Florida, United States

Invesclinic US LLC

Fort Lauderdale, Florida, United States

Luminous Cinical Research- South Florida Urgent Care

Miami, Florida, United States

Entrust Clinical Research

Miami, Florida, United States

DBC Research

Tamarac, Florida, United States

Affinity Clinical Research, LLC

Tampa, Florida, United States

Clinical Research Atlanta

Stockbridge, Georgia, United States

Willis-Knighton Physcian Network

Bossier City, Louisiana, United States

Ascension St John

Bartlesville, Oklahoma, United States

Ascension St. John

Tulsa, Oklahoma, United States

Invesclinic US LLC

Edinburg, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

Next Level Urgent Care

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

PUL-042-501

Identifier Type: -

Identifier Source: org_study_id